Phase 2 Trial of FT2109 for the Treatment of Psoriatic Arthritis

NCT07869134 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: FT2109-2201
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will investigate if the study medicine FT2109 can treat symptoms of active Psoriatic Arthritis (PsA). This study assesses the safety and efficacy of FT2109 in adult participants with active PsA who may or may not have been treated previously with advanced therapy and who may be on stable background therapy. In this study, researchers will look at different doses of FT2109 compared to placebo (a treatment with no active study drug in it). Researchers will try to learn if at least one of the study doses of FT2109 works better than placebo to treat PsA symptoms.

Conditions

Psoriatic Arthritis (PsA)

Keywords

FT2109; Psoriatic Arthritis (PsA); Joint Diseases; Skin Diseases; Spondylarthropathies; Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who achieved an American College of Rheumatology (ACR) 20 response at Week 12

  The ACR20 response is defined as the proportion of participants with at least a 20% improvement in tender joint count (TJC) out of 68 joints, a 20% improvement in swollen joint count (SJC) out of 66 joints, and a 20% improvement in three of the following five criteria: participant pain, participant global assessment of disease, physician global assessment of disease, physical functioning assessment (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).

  Week 12

Secondary Outcomes (7)

• Incidence of TEAEs, SAEs, and clinically significant laboratory findings, vital signs, and 12-lead ECGs

  Baseline to Week 16

• Proportion of participants with ACR20 response at Weeks 2, 4, and 8

  Baseline to Weeks 2, 4, and 8

• Proportion of participants with ACR50 and ACR70 response at Weeks 2, 4, 8, and 12

  Baseline to Weeks 2, 4, 8, and 12

• Proportion of participants with MDA and VLDA at Weeks 2, 4, 8, and 12

  Baseline to Weeks 2, 4, 8, and 12

• Change from baseline to Weeks 2, 4, 8, and 12 in DAPSA score

  Baseline to Weeks 2, 4, 8, and 12

Study Arms (3)

Arm 1

EXPERIMENTAL

Drug: FT2109 Dosing Regimen 1

Arm 2

EXPERIMENTAL

Drug: FT2109 Dosing Regimen 2

Arm 3

PLACEBO COMPARATOR

Drug: Matching Placebo

Interventions

FT2109 Dosing Regimen 1 DRUG

Administered daily for 12 weeks

Arm 1

FT2109 Dosing Regimen 2 DRUG

Administered daily for 12 weeks

Arm 2

Matching Placebo DRUG

Administered daily for 12 weeks

Arm 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Body mass index (BMI) within the range 18 to 40 kg/m2
• Diagnosed with PsA for ≥6 months, and meeting Classification Criteria for Psoriatic Arthritis (CASPAR) at screening
• Have active PsA: ≥3 tender joints and ≥3 swollen joints at screening and baseline and having hsCRP \>0.3 mg/dL (3 mg/L)
• Having active plaque psoriasis (≥1 lesion ≥2cm) or nail psoriasis at screening
• Biologic disease modifying anti-rheumatic drug (bDMARD) or targeted synthetic DMARD (tsDMARD) experienced participants can have received (a) up to one bDMARD (excluding TNF and IL-17 targeting therapies), and (b) up to one tsDMARD (excluding JAK targeting therapies)
• bDMARD or tsDMARD naïve participants must have failed (a) at least one but no more than two csDMARDs AND/OR (b) Apremilast

You may not qualify if:

• Presence of other inflammatory or autoimmune conditions, including but not limited to rheumatoid arthritis, primary ankylosing spondylitis or non-radiographic axial spondyloarthritis without psoriasis, systemic lupus erythematosus, drug-induced dermatosis, inflammatory bowel disease, or Lyme disease
• Current non-plaque forms of psoriasis (e.g., erythrodermic, guttate, or pustular psoriasis)
• Use of \>10mg/day prednisone equivalent or change in oral glucocorticoid dosage within 4 weeks prior to Baseline
• Received targeted intra-articular, trigger point, tender point, intra-bursa, or intra-tendon sheath surgical or pharmacological treatment within 8 weeks of the Screening Visit
• Undergone surgical treatment for PsA including synovectomy and arthroplasty in more than 3 joints and/or within the last 12 weeks prior to the Screening Visit.

Sponsors & Collaborators

• Forward Therapeutics: lead

MeSH Terms

Conditions

Arthritis, Psoriatic; Joint Diseases; Skin Diseases; Spondylarthropathies

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Psoriasis; Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Central Study Contacts

Clinical Operations

CONTACT

857-285-4610; clinicaltrials@forward-tx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share